MBi Nutraceuticals Recalls Stomach Calm and Other Homeopathic Products
MBi Nutraceuticals is voluntarily recalling Stomach Calm and other homeopathic products due to inadequate manufacturing controls.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and is a voluntary precautionary recall due to lack of processing controls, with no specific reported illnesses or injuries mentioned in the source text.
Plain-English summary
MBi Distributing Inc. dba MBi Nutraceuticals is voluntarily recalling all lots of several homeopathic products, including Stomach Calm, Teething Drops, Nausea Drops, Intestinal Colic Drops, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir. The recall includes products within their expiration dates.
The recall is being conducted due to a lack of adequate controls during the manufacturing process. The specific product identified in the structured data is Stomach Calm, Calms Upset Stomach and Aids in Treatment of Simple Diarrhea, 8 fl. oz. liquid in an amber PET bottle. The affected lot number is 14093001 with an expiration date of 09/2020. The distribution was nationwide in the USA.
Consumers should stop using these products and return them to the place of purchase for a refund or contact the recalling firm for further instructions.
The recalled product
- Product
- Stomach Calm, Calms Upset Stomach and Aids in Treatment of Simple Diarrhea, 8 fl. oz., liquid 8 ounce amber PET bottle with Black CRC Cap, MBi Nutraceuticals Lindon, UT 84042. Bar Code: 3 58301 38414 2
- Manufacturer
- MBi Distributing Inc. dba MBi Nutraceuticals
- Category
- Drug — Homeopathic
- Hazard
- Affected units
- 343
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: 14093001
- EXP 09/2020
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by MBi Distributing Inc. dba MBi Nutraceuticals under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
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